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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, January 2008
First Received: June 30, 2006   Last Updated: January 23, 2008   History of Changes
Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00600301
  Purpose

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.


Condition Intervention Phase
Diffuse Diabetic Macular Edema
Drug: Triamcinolone Acetonide and Bevacizumab
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Diffuse diabetic macular edema
  • Non proliferative diabetic retinopathy
  • No VPP previa
  • No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

  • Proliferative diabetic retinopathy
  • Previous pars plana vitrectomy
  • Previous treatment with diabetic macular edema
  • Focal macular edema
  • Macular Ischemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600301

Contacts
Contact: Maximiliano Gordon, MD 10841400 ext 1171, 1172 retinamex@yahoo.com

Locations
Mexico, D.F.
Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico D.F., D.F., Mexico, 04030
Contact: Maximiliano Gordon, MD     10841400 ext 1171, 1172     retinamex@yahoo.com    
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Maximiliano Gordon, MD APEC
  More Information

No publications provided

Study ID Numbers: APEC-OO13
Study First Received: June 30, 2006
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00600301     History of Changes
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:
Macula
Edema

Study placed in the following topic categories:
Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate
Bevacizumab
Angiogenesis Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone
Retinal Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009